This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Time to Recurrence [ Time Frame: Recurrence of cancer in the bladder during 24 months of follow-up ]

Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).

Secondary Outcome Measures:

Recurrence Rate at 24 Months [ Time Frame: 24 months ]

Measurement the number of participants with the recurrence at 24 months.

For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening?

Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator?

Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?

Has the patient ever received apaziquone?

Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?

Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?

Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?

Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma?

Does the patient have or has the patient had micro-papillary transitional cell carcinoma?

If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past?

Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years?

Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L?

Does the patient have a screening hemoglobin < 10 mg/dL?

Does the male patient have a serum PSA > 10 ng/mL?

Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive?

Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study?

Has the patient participated in an investigational protocol within the past 90 days?

Is the patient pregnant or breast feeding?

Does the patient have a life expectancy of <3 years?

Has the patient had any other malignancy or received therapy for any malignancy in the last five years except

non-melanoma skin tumors

stage 0 (in situ) cervical carcinoma

undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer?

Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent?

Does the patient have tumor in a bladder diverticulum?

Does the patient have a known allergy to red color food dye?

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410565